gammaCore-S 10009-40601Recalls & reported problems
electroCore, Inc. · gammaCore-S 300 is a hand-held portable device consisting of an outer plastic case, a battery, signal generating and amplifying electronics, LED and horn (to indicate device status), and a pair of stainless steel skin contact or stimulation surfaces. gammaCore-S 300 uses two buttons to power on the device and for operator control of the signal amplitude / stimulation intensity. The device operating status is visible on a LCD display screen. Caps are provided to cover the stimulation surfaces when the device is not in use. Conductive electrode gel is provided for use with the device. The gammaCore-S 300 device produces a low voltage electric signal consisting of five 5000 Hz pulses that are repeated at a rate of 25 Hz. The waveform of the electric pulses is approximately a sine wave with a peak voltage limited to 24 Volts when placed on the skin and a maximum output current of 60mA. The signal is transmitted through the skin of the neck to the vagus nerve. The device allows up to 30 seconds for the operator to position and adjust the stimulation intensity, treatment is intended to be applied for 90 seconds (the treatment automatically stops 120 seconds after the device is powered on). Each device allows for multiple treatments (up to 300 2-minute treatments) over a 31-day period that commences the first time the unit is powered on and the stimulation intensity is raised to 5 or more. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815203020010), received between Oct 24, 2018 and Oct 24, 2018 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Ambulation or Postural Difficulties1
- Numbness1
- Swollen Lymph Nodes1
- Twitching1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem
PATIENT EXPERIENCED A/E AFTER USING THE DEVICE FOR THE 6TH STIMULATION, APPROXIMATELY 5 MINUTES AFTER TREATMENT. SHE EXPERIENCED NECK TWITCHING, LYMPH NODE AND NECK WERE SWOLLEN AND LEFT ARM WAS NUMB AND UNABLE TO MOVE, WENT TO THE EMERGENCY ROOM.
Patient problems: Ambulation or Postural Difficulties; Numbness; Swollen Lymph Nodes; Twitching
MAUDE report 8002406 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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